3 Life Science Industry Challenges Increased drug development time and cost Average time-to-market is 10 to 15 years Average cost is $1B Increased regulations and market requirements Increased competition requires process improvements 90% of corporate memory is on paper 15% - average time reading the right information 50% - average time spent searching for information 19 - average times a document gets copied 25% - average annual document growth 3

6 Regulated documents Our service offering Fixed offer of the Regulated Documents solution Installation together with your IT team Avoid budget risks Use of trial licenses for all software components for a limited period Optionally: installation and configuration of SharePoint if not already there Implementation of the Regulated Documents solution through a joint implementation project based on GAMP Including user training (train the trainer) Including design, user and administration documentation Optional support contract (4 hour response window through remote access) 6

11 Document process 1 Create document Creation based upon controlled document templates The workflow automatically places metadata into the new document In the basic setup reviewing and approval is combined, but can be easily separated 11

12 Create document screenshots 12

13 Create new document - screenshot Forms based on InfoPath Optional: ASP.NET forms In both cases your IT team can modify the forms themselves if you have the proper tooling 13

24 Software Components of the Regulated Documents solution 1. Microsoft Office 2010/2013 Word, Excel, Powerpoint for editing Outlook for receiving workflow task notifications 2. SharePoint 2010 (2013 soon) Enterprise license if InfoPath required Standard license if forms based on ASP.NET or K2 SmartForms 3. InfoPath Basic solution uses forms based on InfoPath InfoPath comes with an Enterprise license and fits companies with a clear vision on how to optimize business processes throughout the company If required, forms can be delivered as ASP.NET forms including source code 4. K2 BlackPearl (http://www.k2.com) A Visual Workflow tool that enables you to easily model and execute processes according to your way of working (also see 21CFR Part11 statement here) 5. ARX cosign (www.arx.com) Tool for digitally signing documents integrated in Regulated Documents Can be used within Regulated Documents, but also adhoc for signing contracts, purchase orders and so on so the entire organisation can benefit from paperless signing documents. 24

25 Component justification Why Microsoft Office? Your users already use Word, Excel, Powerpoint and Outlook today. Why SharePoint? SharePoint rapidly becomes the default information platform and links easily with Microsoft Office and other third party products. Why InfoPath? Companies that have a clear vision on how to optimise their business processes will need to be able to easily create solutions with electronic smart forms and workflows; InfoPath reduces the need for developer hours and allows for faster delivery of new solutions within your company. Also see here. Why K2? SharePoint doesn t offer rich workflow functionality that allows for automation in a fast and graphical way. K2 allows for creating workflows without developers. Also see here. K2 fits in a regulated environment, see here. However, if your organisation has no need for further process automation, we can offer this concept based on SharePoint 2013 workflows as well. Why cosign? Lots of processes become automated, but when it comes to signing, most companies still print on paper. This slows down processes and is not completely traceable. cosign offers state-of-the-art digital signing solutions that can be used from within Microsoft Office. See here. 25

27 Technical Document creation workflow This is an actual workflow in K2 Workflow Designer; advantage of using K2 is that processes as delivered can easily be modified to your needs with a graphical interface 27

28 Regulated Documents more than tooling! Ensure proper project management Choose an approach based on GAMP so the solution can be validated Form the right project team You are in charge of the project Business in the driver seat Consultants can help you making informed decisions and realise solutions Do not leave project execution to software vendors Introducing a Regulated Documents solution means changing the way people work Proper training Stay focused on changing behaviour 28

30 Summary Industry issues Time and costs of product development in a regulated environment increase Operational efficiency must be improved Still a lot of manual paper handling Regulated Documents Solution for SharePoint Automated creation and management of submission ready documents Integration with familiar editors fits Microsoft environment Ease of implementation Configured based on standard components No need for external consultants for future changes Note: when using ASP.Net Forms instead of InfoPath, adding new fields requires Visual Studio and probably does require external consultancy Adherence to regulatory requirements 30

31 OpenDocs Company overview Founded in 2001 Consultants of medior/senior level specialised in SharePoint, K2, Livelink and complementary products Services ranging from business consultancy to IT Support Enterprise Content Management Specialists 31

32 Customers 32

33 Thank you for your attention! This Regulated Document concept has been built for OpenDocs customers as separate projects; however, it s our ambition to serve more customers in regulated environments by delivering proven solutions that can be tailored to suit a specific way of working. Our concepts are based on products of market leaders and never contain OpenDocs proprietary code or products. Feel free to contact us for a demonstration. OpenDocs bv Het Wielsem BW s-hertogenbosch The Netherlands +31 (0)

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